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A new beta-lactamase-stable oral cephem antibiotic, cefixime (CFIX), was evaluated for safety, efficacy and pharmacokinetics in children. CFIX was effective in 19 of 20 cases (95%) with bacterial infections. The drug was especially effective against the cases of pneumonia due to beta-lactamase-producing H. influenzae or B. catarrhalis. Pharmacokinetic parameters of CFIX (3 mg/kg) with premeal administration were as follows: Kel 0.328 +/- 0.066 hr-1, T 1/2 2.14 +/- 0.36 hrs, AUC 10.9 +/- 8.7 micrograms X hr/ml, and Vd/F 1.64 +/- 1.42 L/kg. In most of the cases tested, the urinary excretion rate in 12 hours was 5 to 17%. A dose of 3 mg/kg twice daily seems to be adequate for a regular treatment.

Cefteram pivoxil (CFTM-PI) was administered to 37 patients with acute febrile upper or lower respiratory infections and 3 patients with urinary tract infections at 10 mg/kg/day divided into 3 portions. Good clinical effects were observed in all the cases. As for the bacteriological effect, the evaluable 24 strains (60.0%) were eradicated among 43 strains identified in 37 cases with the treatment with CFTM-PI. Only 2 strains were eradicated among 9 strains of Staphylococcus aureus. Among 3 patients with urinary tract infections with Escherichia coli, 2 strains were eradicated from urine after the administration of CFTM-PI. Four cases showed mild diarrhea among 40 cases. It was not clear whether the diarrhea was due to the administration of CFTM-PI.